36C10B19C0019-001.pdf

Control Number TAC-19-50781

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for firm-fixed price (FFP) contract to Cerner Government Services, Inc. (Cerner) for continued remote hosting services for the Cerner Millennium PathNet Laboratory Information Management System (LIMS) as well as remote hosting of the data from the Genomic Laboratory and minor maintenance to software components of the exisiting

LIMS.

3. Description of Supplies or Services: The proposed action is to obtain continued services for Remote Hosting (RH) for a technology platform, System Management Services (SMS), Application Management Services (AMS), Disaster Recovery (DR) Services, management and technical support for Cerner Millennium PathNet LIMS which is currently being used at the VA Medical Center (VAMC) in Huntington, West Virginia (WV), hereinafter referred to as the Alpha site. Cerner Millennium PathNet LIMS is an industry-leading laboratory system(s) that supports the VA Pathology and Laboratory Medicine Service by supporting the VA business process including laboratory specimen collection, processing and providing high quality laboratory test results for veterans. The hosting environment is required to meet all applicable VA specifications as well as minimize short and long term risks regarding application availability and disaster recovery. In addition, the proposed effort for technical support includes all services for operations and maintenance. Additionally, DR, high availability, and business continuity metrics are critical elements in the scope of the required hosting environment. In Fiscal Year (FY) 2018, the Genomic Laboratory Information Management System (LIMS) Phase II was awarded to Cerner. Phase II involves the implementation of the full Cerner Millennium Helix configuration developed in the Phase I non-production environment into the current Huntington VAMC non-production and production environments. The Contractor shall only remote host the Genomic Laboratory data for the Alpha site. Also, there is an optional task requirement for minor maintenance of the existing Cerner Millennium PathNet LIMS, specifically this includes maintenance to the operating system layers, communication layers, and system software layers. This maintenance is required to ensure the Cerner Millennium PathNet LIMS remains operational. The period of performance is January 1, 2019 through December 31, 2019 for the base period with three, 12-month option periods for remote hosting and associated services of the Cerner Millennium PathNet LIMS, as well as remote hosting of the Genomic Laboratory data, and an optional task for a maintenance of the Cerner Millennium PathNet software.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

LSRP Remote Hosting Control Number TAC-19-50781

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is Cerner, 10200 Abilities Way, Kansas City, Missouri. Cerner is the only source capable of providing VA with the remote hosting and associated services to support the Alpha site Cerner Millennium PathNet LIMS and Genomic Laboratory requirements. Cerner Millennium PathNet LIMS and supporting genomic laboratories are Cerner proprietary laboratory applications. In the 2005 award of the original development contract, the Department of Defense (DOD) was the lead agency. In 2009, the DOD decided not to continue with the Laboratory System Reengineering Project (LSRP) and the VA assumed sole responsibility for the effort.

Repeated inquiries by the VA during October 2009, July 2010, July 2011, December 2012, October 2015, and November 2018 to Cerner requesting interest to sell Millennium PathNet technical data package to the Government have been declined.

This lack of technical data with the Cerner Millennium PathNet LIMS and Genomic Laboratory applications does not allow VA the ability to adequately define the applicable form, fit, function, interoperability and interface requirements necessary to allow for competition with other commercial vendors for remote hosting. Further, given the lack of technical data available to VA, Cerner is the only source capable of meeting all the following VA requirements relating to RH, SMS, AMS, DR, management and technical support:

a) High availability and redundancy: N+1 redundancy (defined as a system configuration in which multiple components (N) have at least one independent backup component (1) to ensure system functionality continues in the event of a system failure). To be at a level of N+1, the overall system integrity will not be impacted by the failure of any one component, and should continue to function at acceptable performance levels after the loss of any component.

Without knowledge of the proprietary configuration, no other source is capable of providing the required redundancy.

b) Full DR Support: The data center must meet TIER IV standards with purposeful excpetions(TIA/EIA SP-3-0092), TIA/EIA-942). The buildings and all components need to survive enhanced Fujita Scale 5 tornadoes and meet or exceed Federal Emergency Management Agency P-361 standards. The data center must meet N+1 redundancy where multiple components (N) have at least one independent backup component (1) to ensure system functionality continues in the event of a system failure. The Contractor shall ensure that multiple copies of the primary Oracle databse are online at any given time and incremental archive logs are stored on separate storage guaranteeing quick recovery from any database issues including corruption.

A lack of familiarity of Cerner Millennium PathNet and genomic laboratories or any similar applications by other sources precludes any other commercial contractor from being able to satisfy VA DR requirements.

c) Technical Support: Experienced Cerner Millennium PathNet LIMS technical support shall be available 24 hours a day, 7 days a week, and 365/366 days a year. Required support shall have a comprehensive working knowledge of how Millennium PathNet LIMS and genomic laboratories operate from the backend and front-end. The Cerner remote hosting services are required to manage and support it Cerner Millennium PathNet LIMS, the operating systems, Oracle, and Citrix. Cerner is the only source with extensive knowledge of its proprietary application that enables it to provide the required technical support of any hosting infrastructure and for the applications themselves.

Cerner’s Millennium PathNet LIMS is the only laborarory information management system that meets the Huntington VAMC’s unique functional requirements of laboratory interoperability in a Remote Hosting Option (RHO) environment. Cerner’s Millennium PathNet LIMS remote hosting and associates services are required and can only be performed by Cerner. Cerner is the only source due to proprietary code, testing, maintenance releases synchronization, and systems interoperability of the existing laboratory infrastructure specifically designed to work with the Huntington VAMC, Cerner RHO, and the Huntington Veterans Health information Systems and Technology Architecture (VistA) database that is hosted at the Warner Robbins Defense Information Systems Agency Defense Enterprise Computing Center. This is primarily due to multiple pieces of laboratory hardware/software and their respective support efforts being highly dependent on one another. In particular, the Cerner instrument BUS (iBUS) is the backbone that ties all the different components together using the respective LIMS solution protocols and interfaces. In addition, Cerner’s RHO utilizes a proprietary configuration consisting of: Citrix NetScalar load balancer designed to handle high volume message traffic, Millenmium PathNetapplication Server, and an Oracle Database Server. Selection of another LIMS solution would required architecturing, designing, and implementing a completely new RHO to interface with the Huntington VAMC and Warner Robbins VistA database. Another factor for consideration is the proprietary communication interfaces between third party vendors such as LabCorp and Quest Diagnostics utilizing Laboratory Electronic Data interchange III. The proprietary nature of the lab information produced is designed to work with the Cerner Millennium PathNet LIMS solution and Genomic Laboratories. A replacement Cerner Millennium PathNet LIMS and Gemomic Laboratory solution would need to reengineer the communication interfaces and protocols to work with the respective products Cerner Millennium PathNet LIMS solution. Cerner’s Millennium PathNet LIMS and Genomic Laboratories are the only laboratory information management system that meets the Governments requirements.

Also, there is an optional task requirement for minor maintenance of the exisiting Cerner Millennium PathNet LIMS, specifically this includes maintenance to the operating system layers, communication layers, and system software layers. Any source must have access to the Cerner proprietary data in order to provide this maintenance. Access to this code is needed to ensure the services provided are properly configured. Degradation of the system would cause operational and performance issues affecting system interfaces, Section 508 and security functionality which puts patient safety at risk and negatively impacts VA’s ability to maintain an Authority to Operate (ATO). System maintenance is critical to patient safety and for the continued use of the Cerner Millennium PathNet LIMS until the scheduled replacement in 2023 by the Cerner EHRM system. Cerner is the only source that has access to the proprietary data of the design and architecture of the Cerner Millennium PathNet LIMS 2015 version, as well as all versions in-between in the maintenance cycle, and all future versions including minor versions that update Cerner Millennium PathNet 2015 version until the scheduled replacement in 2023.

As the actual developer of the proprietary code, Cerner is the only source that has the ability to either immediately begin creation of patches to the proprietary software that could better meet VA requirements, or to incorporate updates into future Cerner releases based on observations and experience with updating the VA’s implementation of Cerner Millennium PathNet. Only Cerner has the ability to update the code to address Section 508 issues, or code issues that can resolve any security issues encountered with the new versions that would be necessary to address in order to keep the system operational. No other source has the ability to plan for and produce current and/or future code updates for Cerner that could resolve any issues encountered. Cerner is the only source that has access to the proprietary code base required to successfully maintain Cerner Millennium PathNet 2015 software version.

6. Efforts to Obtain Competition: Market research was conducted, the details of which are in section 8 of this justification. The market research conducted did not yield any potential sources, other than Cerner, who could meet all of the Government’s requirements. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Federal Busines Opportunities (FBO) website in accordance with FAR Part 5.201. Any proposals that are received shall be envaluated.

7. Actions to Increase Competition: The Government had anticipated replacing the LIMS alpha site solution currently in use at the Huntington, WV VAMC between 2017 and 2018 with an interoperable VA-Department of Defense (DoD) integrated Electronic Health Record (iEHR) Lab solution. However, several unanticipated events occurred during the past three years that have rendered the iEHR Laboratory solution as a non-viable replacement option. VA began planning the replacement requirement for a new LIMS however, this requirement was centered on VA utilizing VistA. This was to be the enterprise wide lab solution to replace VistA Lab. It was to be a competitive procurement with award and development commencing in fiscal year 2017 and implementation schedule in 2018. However, in 2018 VA determined that VistA could no longer meet VA’s needs. Specifically, VistA could not meet all of VA’s electronic health record requirements that were established in late 2017. In May 2018, VA awarded Cerner Government Services, Inc. a contract for a new EHRM system to replace the VA long term VistA System with a commercial health care system application. The new EHRM system encompasses a new LIMS that will replace the current LIMS solution that is being supported under this proposed action. It is antipcated that the EHRM system will replace Cerner’s Millennium PathNet LIMS, in 2023. Moving forward, all future requirements will be to host and maintain this existing LIMS until the new Cerner LIMS solution is implemented.

The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed.

8. Market Research: The Government’s technical experts performed market research in May 2018 by conducting internet searches for a LIMS Remote Hosting Option (RHO).

VA researched other vendors such as Soft Computer Consultants Inc. (dba SCC), Labware Inc., and Thermo Fisher Scientific Inc. for LIMS sustainment support.

Although the vendors can provide a LIMS solution, they are unable to provide the support for the Cerner iBUS, Cerner RHO, and VistA interface as required for the Cerner Millennium PathNet LIMS solution due to proprietary code, testing, upgrade releases synchronization, and systems interoperability and compatibility issues with the existing infrastructure. The Huntington site is scheduled to receive the new Cerner LIMS solution in 2023.

Additional Market Research was conducted through issuance of a Request for Information (RFI) on the Federal Business Opportunities website on November 6, 2018.

The RFI closed on November 16, 2018 and one response was received from Cerner Government Services, Inc. The Millennium PathNet LIMS is a Cerner proprietary laboratory application with proprietary source code. Access to this code is critical in the event a VistA patch is implemented that affects the operation of any of the components that comprise the Cerner Millennium PathNet LIMS. Based on the market research and review of the Cerner’s capability statement, the Government’s technical experts have determined that Cerner Government Services, Inc. is the only source that could meet all of the Government’s requirements.

9. Other Facts: None.